System and method for out-of-band pairing of sterile device with non-sterile device

ABSTRACT

System and methods for out-of-band pairing sterile medical device with non-sterile devices without compromising sterility thereof. A system includes a sterile medical device; a non-sterile computing device; at least one near field communication (NFC) tag; and a sterile packaging enclosing the sterile medical device. In one example, a sterile percutaneous needle guidance device needs to pair and communicate with a non-sterile computer. The sterile device has an NFC tag embedded in the sterile device and an NFC tag embedded in the sterile packaging. The two NFC tags include identification information duplicate of each other. Before opening the sterile packaging either NFC tag can be scanned with the non-sterile device to initiate wireless pairing. If the sterile package is opened before pairing, the NFC tag contained in the packaging can be brought out of the sterile field and scanned with the non-sterile computer thus preserving the sterility of the sterile device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation, and claims the benefit, ofco-pending U.S. patent application Ser. No. 17/023063 filed Sep. 16,2020, which claims priority to U.S. provisional application 62/902031,filed Sep. 18, 2019, the disclosures of which are incorporated byreference herein in their entirety.

BACKGROUND INFORMATION Field of Disclosure

The present disclosure relates to medical devices. More particularly,the disclosure exemplifies a system and method for out-of-band pairingof a sterile device with a non-sterile device in a medical environmentsuch as, for example, an operating room.

Description of Related Art

Sterilization refers to any process that effectively renders anysurface, equipment or article free from viable microorganisms. Sterilityand its maintenance, together with the prevention of cross-infection,are at the top of any list of critical factors in patient care. Inpractice, Sterility Assurance Level (SAL) is used as a measure of thesurvival level of microorganisms after terminal sterilization. Itemssuch as medical devices can only be categorized as “sterile” if thechance of an item remaining contaminated after sterilization is lessthan or equal to one chance in a million. Therefore, the packagingaround medical devices is carefully designed so that it allows thosedevices to be sterilized, provides a microbial barrier and maintainssterility effectively up to the point of use. This type of packagingcreates a sterile barrier system (SBS) and is an essential part of asterile medical device.

Single use sterile medical devices are prevalent in the medical deviceindustry. Sterile medical devices are usually delivered to a medicalfacility (e.g., hospital) in terminally sterile packaging and are usedonce for a single patient and discarded following the procedure. Singleuse sterile devices are often preferred over reusable devices due to thedecreased risk of improper cleaning, disinfecting, and lower chance ofinfection or cross contamination. In the past, in order to bedisposable, sterile medical devices were typically made from low-gradeinjection molded plastics and most single-use sterile devices did notinclude electronic components.

Recently, the internet of things (IoT) industry has revolutionized theconsumer electronics market with the advent of wirelessly connecteddevices. With the rapid growth of the IoT industry and the low cost ofelectronic components, several medical device manufacturers now producesingle use disposable medical devices which include highly advancedelectronic components that must interact with non-disposable medicalequipment. To that end, many wireless communication protocols, includingwireless fidelity (WiFi), Bluetooth, Z-Wave, ZigBee, near fieldcommunication (NFC), radio frequency identification (RFID), IPv6 overlow-power wireless area networks (6LoWPAN), etc., have been developed tofacilitate the proliferation of medical devices capable of wirelesslyconnecting to each other.

Near field communication (NFC) is a type of short-range radio frequencycommunication technology, operating at about 13.56 MHz and in abandwidth of about 2 MHz, which allows for read-only and read-writecommunications between a NFC-enabled RF device reader and a NFC-enableddevice. NFC operation is based on inductive coupling between two loopantennas, which allows for sharing of power and data between NFC-enableddevices at a short distance. Typically, for proper operation, thedistance between a NFC-enabled reader and a NFC-enabled device needs tobe about under about 10 centimeters (cm) and more preferably about 5 cmor two inches.

Security is of paramount importance in wirelessly connected medicaldevices and thus wireless encryption is a necessity. Also, for devicesrequiring an unsterile and sterile component to interface with eachother, medical device packaging is an important aspect to minimize thechance of loss of sterility. However, the pairing process of a sterilemedical device to a non-sterile medical device is prone to accidentalloss of sterility when a sterile component comes into contact with anunsterile user or unsterile component.

Many device manufacturers use near field communication (NFC) orradio-frequency identification (RFID) technologies to exchange deviceidentifying information such as a wireless identifier and an encryptionkey out-of-band between devices in order to encrypt communicationssecurely. This process is referred to as out-of-band (OOB) pairing. OOBpairing is a secure way of sharing a wireless identifier and/orencryption key without using the main communication channel or protocol.In the case of Bluetooth enabled devices, for example, OOB pairing coulduse a protocol other than Bluetooth; for example, pairing could use adifferent 2.4 GHz protocol, such as direct WiFi or ZigBee or 6LoWPAN,etc., or it could use a different communication frequency, such as NFC.Bluetooth OOB pairing using NFC is well known. See, for example,Application Document “Bluetooth® Secure Simple Pairing Using NFC”published by NFC Forum, Inc., 2014. As explained above, OOB pairingusing NFC and RFID technology requires devices to be in close proximityto each other or to even touch each other. This pairing process of asterile medical device to a non-sterile medical device is prone toaccidental loss of sterility when a sterile component comes into contactwith an unsterile user or unsterile component. However, the issue ofmaintaining appropriate sterility during the pairing process has notbeen addressed by the consumer electronic industry.

For example, U.S. Pat. No. 9,800,663, “Associating Dialysis AccessoriesUsing Near Field Communications”, describes pairing a Dialysis machinewith Dialysis accessories such as a blood pressure cuff using NFCtechnology to exchange a wireless identifier unique to the dialysismachine accessory device. The dialysis machine then uses the wirelessidentifier to establish a wireless communication with the accessorygranting permissions to the dialysis accessory to control functions ofthe dialysis machine. Similarly, patent application publication US2014/0273824, “Systems, Apparatus and Methods Facilitating SecurePairing of an Implantable Device with a Remote Device Using Near FieldCommunication”, describes exchanging information with an implantabledevice using NFC protocols. In this case, an implantable medical devicecontains a NFC component externally attached to the implant. The NFCcomponent is configured to transmit identification informationassociated with the implantable device to a reader using the NFCprotocol. Exchange of this information allows for pairing of the implantwith an external remote device over a secondary communication protocolother than NFC, such as Bluetooth. Also, patent application publicationUS 2017/0091498 discloses using RFID devices integrated or included inthe packaging of medical devices to facilitate a secure and authorizedpairing with a host system. In publication US 2017/0091498, the medicaldevice is a wearable sensor, a sensing patch attachable to a patient, ora sensing patch used in cooperation with medication administration to apatient. Therefore, although the RFID may ensure secure pairing of themedical device, sterility of the medical device is not maintained whenthe medical device is applied to the patient.

In U.S. Pat. No. 9,800,663, none of the dialysis accessories are sterileand thus this patent does not address the need of pairing a steriledevice to a non-sterile device without compromising sterility.Similarly, publication US 2014/0273824 is limited to implantable medicaldevices only, and it covers exchanging information over NFC only afterthe implant is implanted into the patient. Therefore, the need ofpairing a sterile medical device with a non-sterile medical devicewithout compromising sterility remains.

Indeed, the main barrier for adoption of these wireless technologies insterile medical devices is the challenge of secure wireless pairing of asterile medical device with another non-sterile and non-disposabledevice such as a computer without compromising the sterility of thesterile disposable device. Physical interaction between a sterilemedical device and a non-sterile medical device will inevitably renderthe sterile device non-sterile. This challenge is unique to theapplication of these wireless technologies to medical devices and thushas not been addressed by the consumer electronic industry.

SUMMARY OF EXEMPLARY EMBODIMENTS

According to at least one embodiment of the present disclosure, there isprovided a system and method for out-of-band pairing a sterile medicaldevice with a non-sterile computing device without compromisingsterility of the sterile medical device.

The system includes a sterile medical device; a non-sterile computingdevice; at least one NFC (near field communication) tag; and a sterilepackaging enclosing the sterile medical device. In one example, asterile percutaneous needle guidance device needs to pair andcommunicate with a non-sterile computer. The sterile guidance device hasa first NFC tag embedded in the device and a second NFC tag embedded inthe sterile packaging. The two NFC tags are duplicate of each other.Before opening the sterile packaging either NFC tag can be scanned withthe non-sterile device to initiate wireless pairing. If the sterlingpackaging is opened before pairing, then the second NFC tag contained inthe packaging can be brought out of the sterile field and scanned withthe non-sterile computing device thus preserving the sterility of thepercutaneous needle guidance device.

These and other objects, features, and advantages of the presentdisclosure will become apparent upon reading the following detaileddescription of exemplary embodiments of the present disclosure, whentaken in conjunction with the appended drawings, and provided claims.

BRIEF DESCRIPTION OF DRAWINGS

Further objects, features and advantages of the present disclosure willbecome apparent from the following detailed description when taken inconjunction with the accompanying figures showing illustrativeembodiments of the present disclosure.

FIG. 1 is a diagram of an exemplary system for pairing a sterile medicaldevice with a non-sterile computing device using short-range near fieldcommunication protocols.

FIG. 2 is a flowchart of an exemplary process for pairing a sterilemedical device with a non-sterile computing device where, duringpairing, the non-sterile device generates identification information andwrites it into a NFC tag of the sterile device.

FIG. 3 is a flowchart of an exemplary process for pairing a sterilemedical device with a non-sterile computing device wherein, duringmanufacturing, identification information is written into the NFC tag ofthe sterile device.

FIG. 4 is a diagram of an exemplary system for pairing a sterile medicaldevice with a non-sterile computing device using short-range near fieldcommunication protocols.

FIG. 5 is a flowchart of an exemplary process for pairing a sterilemedical device with a non-sterile computing device wherein, duringmanufacturing, identification information is written into a NFC tag ofthe sterile device and into a NFC tag of the sterile packaging.

FIG. 6 is a diagram of an exemplary system for preprogramming, duringmanufacturing, identification information into a NFC tag of the steriledevice and into a NFC tag of the sterile packaging.

FIG. 7 is a diagram of an exemplary system for duplicatingidentification information preprogrammed in the NFC tag of the steriledevice onto the NFC tag of the sterile packaging.

FIG. 8 is a diagram of an exemplary system and method for encrypting orpassword protecting the NFC tag of the package and the NFC tag of thesterile device.

FIG. 9 is a diagram of an exemplary system for pairing a sterilepercutaneous needle guidance device with a non-sterile computer withoutbreaking sterility of the sterile percutaneous needle guidance device.

FIG. 10A through FIG. 10E show exemplary GUI prompts for guiding a userto perform a process of pairing a sterile percutaneous needle guidancedevice with a non-sterile computer without breaking sterility of thesterile percutaneous needle guidance device.

FIG. 11 illustrates a further process (method) for out-of-band pairingsterile to non-sterile devices without compromising sterility thereof.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The embodiments are based on the object of providing a system and methodfor out-of-band pairing a sterile medical device with a non-sterilecomputing device without compromising sterility of the sterile medicaldevice.

In referring to the description, specific details are set forth in orderto provide a thorough understanding of the examples disclosed. In otherinstances, well-known methods, procedures, components and circuits havenot been described in detail as not to unnecessarily lengthen thepresent disclosure. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed. As used herein, the term “sterile” refers to itscommon medical definition meaning totally clean and substantially freefrom bacteria or other living microorganisms. Similarly the termsunsterile and non-sterile are interchangeably used to mean not free ofliving organisms and microorganisms, as in an unsterile medicalinstrument or a medical operation done in a non-sterile environment.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached”, “coupled” orthe like to another feature or element, it can be directly connected,attached or coupled to the other feature or element or interveningfeatures or elements may be present. In contrast, when a feature orelement is referred to as being “directly connected”, “directlyattached” or “directly coupled” to another feature or element, there areno intervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown in one embodiment can apply to other embodiments. It will alsobe appreciated by those of skill in the art that references to astructure or feature that is disposed “adjacent” to another feature mayhave portions that overlap or underlie the adjacent feature. When used,term “and/or”, may be abbreviated as “/”, and it includes any and allcombinations of one or more of the associated listed items, if soprovided.

Spatially relative terms, such as “under” “beneath”, “below”, “lower”,“above”, “upper”, “proximal”, “distal”, and the like, may be used hereinfor ease of description to describe one element or feature'srelationship to another element(s) or feature(s) as illustrated in thevarious figures. It should be understood, however, that the spatiallyrelative terms are intended to encompass different orientations of thedevice in use or operation in addition to the orientation depicted inthe figures. For example, if the device in the figures is turned over,elements described as “below” or “beneath” other elements or featureswould then be oriented “above” the other elements or features. Thus, arelative spatial term such as “below” can encompass both an orientationof above and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein are to be interpreted accordingly. Similarly, the relativespatial terms “proximal” and “distal” may also be interchangeable, whereapplicable.

The term “about” or “approximately” as used herein means, for example,within 10%, within 5%, or less. In some embodiments, the term “about”may mean within measurement error. In this regard, where described orclaimed, all numbers may be read as if prefaced by the word “about” or“approximately,” even if the term does not expressly appear. The phrase“about” or “approximately” may be used when describing magnitude and/orposition to indicate that the value and/or position described is withina reasonable expected range of values and/or positions. For example, anumeric value may have a value that is +/−0.1% of the stated value (orrange of values), +/−1% of the stated value (or range of values), +/−2%of the stated value (or range of values), +/−5% of the stated value (orrange of values), +/−10% of the stated value (or range of values), etc.Any numerical range, if recited herein, is intended to include allsub-ranges subsumed therein.

The terms first, second, third, etc. may be used herein to describevarious elements, components, regions, parts and/or sections. It shouldbe understood that these elements, components, regions, parts and/orsections should not be limited by these terms. These terms have beenused only to distinguish one element, component, region, part, orsection from another region, part, or section. Thus, a first element,component, region, part, or section discussed below could be termed asecond element, component, region, part, or section without departingfrom the teachings herein.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a”, “an”, “said” and “the”, are intended to include theplural forms as well, unless the context clearly indicates otherwise. Itshould be further understood that the terms “includes” and/or“including”, when used in the present specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof not explicitly stated. It is furthernoted that some claims may be drafted to exclude any optional element;such claims may use exclusive terminology as “solely,” “only” and thelike in connection with the recitation of claim elements, or it may useof a “negative” limitation.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any aspect described herein as “exemplary”,unless specifically stated, is not necessarily to be construed aspreferred or advantageous over other aspects.

The term “processor” can refer to substantially any logic and/orsoftware-based computing processing unit or device. The term “memory”can refer to volatile memory or nonvolatile memory, or it can includeboth volatile and nonvolatile memory. The memory (e.g., data storage) ofthe embodiments includes any suitable type of information storagecomponent relevant to operation and functionality of a processor.

Near field communication (NFC) is a set of standards for mobile devices,such as smart phones, contactless cards, and similar devices toestablish radio communication with each other by touching them togetheror bringing them into close proximity, usually no more than a fewcentimeters. NFC devices communicate via magnetic field induction, wheretwo loop antennas are located within each other's near field,effectively forming an air-core transformer. Communication is alsopossible between an NFC device and an unpowered NFC chip; an unpoweredNFC chip is called a “NFC tag” or simply “tag”. NFC involves aninitiator and a target; NFC devices take very simple form factors suchas tags, stickers, key fobs, or cards that do not require batteries. NFCpeer-to-peer communication is possible, provided that both devices arepowered. As the names imply, the initiator is the device that initiatescommunication; it also controls the data exchanges. The target device ispassive device that responds to the request from the initiator andaccepts the communication with the initiator to happen. The initiatoractively generates an RF field that can power the passive target. RadioFrequency Identification (RFID) uses essentially the same workingstandards as NFC. However, NFC has an essential extension over RFIDwhich is the communication mode between two active devices. Thus, in thepresent disclosure, the term “NFC tag” also includes the term “RFIDtag”, and/or any other passive tag that communicates via magnetic fieldinduction. An NFC initiator can be, for example, an RFID reader or asmartphone. In proximity of another NFC device, the NFC initiatorinitiates communication then collects information from the target (tag)or runs an action according to the collected information. For example,obtaining identification of a commercial article bearing an NFC tag is abasic example of collecting information. Pairing of a Bluetooth® musicplayer (an NFC initiator) with an active Bluetooth® speaker (an NFCtarget) is a good example of an action resulting from an NFCtransaction.

The term “pairing” refers to a process used in the field of computernetworking for establishing an initial link or connection between twocomputing devices to enable communication between them. For example,Bluetooth pairing is necessary whenever two Bluetooth devices connect toeach other to share resources. An example is the use of Bluetoothcommunication protocol to pair two devices like a set of headphones anda mobile phone or laptop. A Bluetooth pairing process is typicallytriggered automatically the first time a device receives a connectionrequest from a device with which it is not yet paired. In order forBluetooth pairing to occur, a minimum of security information has to beexchanged between the two devices. This security information, such as“password” or “passkey” is a code shared by both Bluetooth devices; thepasskey is used to ensure that both devices/users have agreed to pairwith each other. Out of band (OOB) pairing is a pairing process designedfor scenarios where an out of band communication technique is used todiscover the pairing devices as well as to exchange or transfer securityinformation which would be used in the pairing process.

Currently, some Bluetooth enabled devices, such as smartphones andtablets use NFC to ‘tap to pair’ between devices, and use standardBluetooth protocol for normal communication. Since NFC has veryshort-range communication (about 2 inches or less), the close proximitybetween NFC-enabled devices serves as an assurance that the two devicesare indeed meant to be paired together. Therefore, NFC is a goodcommunications interface for OOB pairing. As an example, for a user whohas a smartphone and Bluetooth headphones, if both devices haveBluetooth and NFC capabilities, the user will initially touch the twodevices together, and is given the option to pair. This is a singletouch process where security information is exchanged between the twodevices under NFC protocol. If the option to pair is confirmed (“YES” isselected), the pairing is successful, and communication between thesmartphone and Bluetooth headphones takes place under standard Bluetoothprotocol.

Throughout the figures, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components, functions or portions of the illustrated embodiments.Moreover, while the subject disclosure will now be described in detailwith reference to specific figures, it is done so in connection with theillustrative exemplary embodiments. It is intended that changes andmodifications can be made to the described exemplary embodiments withoutdeparting from the true scope and spirit of the subject disclosure asdefined by the appended claims.

<FIG. 1>

FIG. 1 illustrates an exemplary diagram of a system 100 including asterile medical device 110 and a non-sterile computing device 150. Themedical system 100 shows the non-sterile computing device 150 pairingwith the sterile medical device 110 via an NFC signal 125 (short-rangesignal), and shows the sterile medical device 110 wirelessly connectingto the non-sterile computing device 150 via a wireless connection 135(long-range signal). In its basic form, the sterile medical device noincludes a processor 112, a memory 116, a wireless transceiver 118, andan integrated or embedded (near field communication) NFC tag 114. Asshown in FIG. 1, the sterile medical device no and the NFC tag 114 areenclosed in a sterile packaging 120. In at least some implementations,the NFC tag 114 may be connected to both the sterile medical device noand the sterile packaging 120 (e.g. by a temporary connection 114 a).Alternatively, as discussed in further detail below, the sterilepackaging 120 may preferably include its own NFC tag.

The processor 112 controls all operations of the sterile medical device110. The processor 152 controls all operations of the non-sterilecomputing device 150. The processor 112/152 may also be referred to as acentral processing unit (CPU). Additionally, the term processor may alsorefer to an integrated circuit (IC), an application specific integratedcircuit (ASIC), a digital signal processor (DSP), a programmable logiccontroller (PLC), and the like. Memory 116, which may include bothread-only memory (ROM) and random access memory (RAM), providesinstructions and data to the processor 112. A portion of the memory 116may also include non-volatile random access memory (NVRAM). Theprocessor 112 typically performs logical and arithmetic operations basedon program instructions stored within the memory 116. Therefore, theinstructions in the memory 116 may be executable to implement at leastpart of the control and process methods of the system 100 describedherein. The sterile medical device no may also include a non-illustrateddigital signal processor (DSP) for use in processing signals. Thesterile medical device no may include non-illustrated components suchas, but not limited to, a power supply (e.g., a battery), a power switch(ON/OFF buttons), and other user-interface components as visual,tactile, and aural components for handling and operating such device.

The NFC tag 114 is a passive, preferably read-only device. The NFC tag114 includes at least an antenna communicatively coupled to anintegrated circuit (IC), and a memory The NFC tag 114 can be any of anNFC® tag, an RFID® tag, a ZigBee® tag, or other like-technology tagembedded in the sterile medical device no and sealed inside a terminallysterile packaging 120. Medical device packaging must not only provideprotection to the product, but it must also communicate what the productis, instructions, warnings and safety information, and other pertinentinformation such as; lot number, sterilization method, expiration date,etc. Sufficient space must be provided on the packaging for conveyingthis information either by printing directly on the package or byapplying a label. Often, there must be also adequate space for theinformation in two or more languages. At least some of the aboveinformation could be provided within the memory of NFC tag 114. Thesterile packaging 120 comprises, for example, a 3D printed package. Andintegrating the identification information about the sterile medicaldevice no into the packaging 120 comprises, for example, adding a RFIDtag, a NFC tag, or an electronic barcode, hologram or watermark encodedin an electronic circuit (smart labels), and combinations thereof intothe 3D printed package which encloses the sterile medical device 110.

The packaging 120 can be of any material and shape conventionally knownin the art. Conventional pouch and tray lid materials mainly consist ofTyvek®, foil and a few clear polymer variations. Conventional traymaterials consist of polyethylene terephthalate glycol (PETG). PETGtends to be the most commonly used material, in particular for additivemanufacturing (3D printing). PETG is transparent, has good mechanicalproperties and is compatible with the most common types of sterilizationmethods. Other materials may include polyvinyl chloride (PVC),polycarbonate (PC), polypropylene (PP) and high impact polystyrene(HIPS). For medical devices, materials and package validation testing isoutlined in ISO standard 11607. Keeping in line with standardrequirements, the packaging 120 may be a hermetically sealed containermade of one or more different types of polymeric substrates or layers.In some embodiments, as mentioned above, the packaging 120 may be formedby 3D printing a container made of, for example, thermoplasticpolyurethane (TPU), polyethylene terephthalate (PET). In otherembodiments, the packing 120 may be made by a polymeric layer or layersof flexible material such as paper, synthetic paper, woven or non-wovensheets of medical grade fabric, polymeric film or sheets, and the like.In further embodiments, the packaging 120 can be made of extruded andmolded polymer materials.

The non-sterile computing device 150 is, for example a general purposecomputer or a modality's console computing resources including, amongother things, a processor 152, a user interface 153, a NFC transceiver154, a memory 156, and a wireless transceiver 158. The processor 152controls all operations of the non-sterile computing device 150. Theprocessor 152 may include a microprocessor which may also be referred toas a central processing unit (CPU), or may include other processor suchas a field programmable gate array (FPGA) circuit board. Memory 156,which may include both read-only memory (ROM) and random access memory(RAM), provides instructions and data to the processor 152. A portion ofthe memory 156 may also include non-volatile random access memory(NVRAM). The processor 152 typically performs logical and arithmeticoperations based on program instructions stored within the memory 156.The instructions in the memory 156 may be executable to implement atleast part of the methods described herein. The user interface 153provides user interface for the system 100 in general. The userinterface 153 may provide an interface for a user (e.g., a doctor, anurse, a technician, or the like) to communicate with the sterilemedical device 110. The user interface 153 may comprise a networkeddevice, such as a tablet, a smart phone, a cellular phone, a laptop, ordedicated electronic hardware. The user interface 153 may be part of, ormay be connected with, the non-sterile computing device 150, ahealthcare facility intranet (e.g., a hospital intranet), or the sterilemedical device 110 directly via physical wires, wirelessly, or both. Theconnection between the user interface 153 and the non-sterile computingdevice 150 or the sterile medical device 110 may be part of an in-roomnetwork. The user interface 153 may prompt the user to confirm treatmentof a patient during a procedure, and once the user confirms, the usermay scan NFC tag 114 of the sterile medical device 110 before (or after)the packaging 120 of the sterile medical device is opened.

In the medical environment, prior to any use, the sterile medical device110 must be paired with the non-sterile computing device 150 preferablybefore the seal on the sterile packaging 120 is broken. However, therecan be events in which the pairing process may be required after thesterile packaging has been opened. The remainder of the disclosureprovides detailed description of processes and algorithms which can beimplemented by the processor 152 of the non-sterile computing device 150and/or the processor 112 of the sterile medical device no to implementout-of-band pairing without compromising sterility thereof.

<FIG. 2>

FIG. 2 is an exemplary flow diagram showing a process (method) ofpairing the sterile medical device 110 with the non-sterile computingdevice 150, such as a computer, without compromising the sterility ofthe sterile medical device 110. In this embodiment, when the packagedsterile medical device no is brought within close proximity (near) theNFC transceiver 154 of the non-sterile computing device 150 (step S202),the NFC transceiver 154 transmits an inductive radiofrequency signal (anNFC signal 125) to the NFC tag 114 of the sterile medical device 110.More specifically, the NFC transceiver 154 of the non-sterile computingdevice 150 energizes an induction coil of the NFC tag 114. This transferof energy causes the NFC transceiver 154 to transfer identificationinformation, (e.g., an encryption key and/or a password) previouslystored in memory 156 to the NFC tag 114 using NFC communicationprotocols (e.g., ISO/IEC 1800-3, ISO/IEC 18092 /ECMA-340, ISO/IEC21481/ECMA-352). That is, according to one embodiment, the non-sterilecomputing device 150 generates and writes identifying information intothe NFC tag 114 of the sterile medical device 110 (step S204).

The “identifying information” includes, but is not limited to, awireless identifier, a password/passkey, and/or an encryption keynecessary for exchanging information between the sterile medical device110 and the non-sterile computing device 150. A wireless identifier mayinclude, for example, a SSID (service set identifier), a MAC (mediaaccess control) address, an IP (internet protocol) address, a UUID,BD_ADDR value, OUI (organization unique identifier), etc., as it isknown to persons skilled in the art. In order to ensure safety, prior towriting the identifying information into the NFC tag 114 of the sterilemedical device 110, it is preferable that the NFC tag 114 is empty. Tothat end, the NFC tag 114 can be configured to accept and store newidentifying information from an NFC writer (e.g., the NFC tag can berewritable).

More specifically, at step S202, the NFC tag 114 of the sterile medicaldevice 110 is scanned by the NFC transceiver 154 of the non-sterilecomputing device 150. At step S204, the processor 152 of the non-sterilecomputing device 150 executes an appropriate software application toread (from memory 156) or generate identifying information, and to writethe identifying information into the NFC tag 114 of the sterile medicaldevice 110. After the sterile medical device 110 has been paired(registered) with the non-sterile computing device 150, the user (e.g.,a physician) may proceed to a sterile area (e.g., an operating room)where the packaging 120 of the sterile medical device 110 can be openedand activated (powered ON) for use. When the sterile packaging 120 isopened, and the sterile medical device 110 is turned on (step S206), thesterile medical device 110 can read (use) the identifying information125 contained in the NFC tag 114 (step S208) to search for a hostdevice. Specifically, the sterile medical device 110 reads theidentifying information from the NFC tag 114, and uses that identifyinginformation (e.g., the identity of the non-sterile device) to securelyestablish wireless communication 135 with the non-sterile computingdevice 150 (step S209). The wireless communication 135 preferably occursover a secondary communication protocol different than the NFC protocol,such as Bluetooth, Direct WiFi, wireless local area network (wirelessLAN), or the like.

In other words, as described above, the NFC protocol may be used forout-of-band pairing between the NFC tag 114 of the sterile medicaldevice 110 and the NFC transceiver 154 of the non-sterile computingdevice 150. On the other hand, wireless communication 135 between thesterile medical device 110 and the non-sterile computing device 150 usesa communication protocol having a higher bandwidth and/or longer rangethan the short-range (near field) of the NFC protocol.

Out-of-band pairing of the NFC tag 114 of the sterile medical device 110with the NFC transceiver 154 of the non-sterile computing device 150 mayuse any of various suitable short-range wireless communicationtechnologies, besides NFC protocol, such as Bluetooth short-range, RFID,ZigBee (IEEE 802.15.4, IEEE 802.15.4a), ANT/ANT+, body area networks(BAN) protocols, Medical Implant Communication Service (MICS), 6LoWPAN,and the like. The wireless communication 135 between the sterile medicaldevice 110 and the non-sterile computing device 150 may use longer rangecommunication technologies, such as Bluetooth Low Energy (BTLE), WiFi inaccordance with the IEEE 802.11 standard, Bluetooth High Speed, DirectWiFi, Ultra Wide Band (UWB), and the like. For maintain high security,the wireless communication between the sterile medical device no and thenon-sterile computing device 150 (signal 135) may be a point-to-pointconnection, such that the data transferred between the two devices willnot have to travel via a large network or the Internet.

An example of the Bluetooth out-of-band short-range carrier isdescribed, for example, in Bluetooth Specification, Version 4, Jun. 30,2010. An example of the Radio Frequency Identification (RFID)out-of-band short-range carrier is described, for example, in ISO 11785(air interface protocol), ISO 14443 (air interface protocol), and ISO15693. An example of the Near Field Communication (NFC) out-of-bandshort-range carrier is described, for example, in ISO/IEC 14443 andISO/IEC 18092.

Referring back to FIG. 1, the NFC tag 114 is a passive, read-onlydevice, fabricated on a thin substrate (e.g., like a sticker). The NFCtag 114 includes at least an antenna communicatively coupled to anintegrated circuit (IC), and a memory configured to store at leastidentification information (e.g., a number, a code, a key, a password,etc.) for identifying the sterile medical device 110 to which it isattached. The NFC tag 114 can be configured to be written-to only onceor multiple times to its memory. Moreover, the NFC tag 114 can beprogrammed (written) during manufacture and/or preferably afterintegration into the sterile medical device 110 (e.g., when the tag isalready attached to the sterile medical device 110). The write operationto the NFC tag 114 can be accomplished using a passkey or other securemethod into an area where further write operations can be preventedunless the passkey is known. The NFC tag 114 preferably does not includeany power source. Instead, NFC tag 114 draws power from the NFCtransceiver 154 which reads and/or writes to NFC tag 114 using magneticinduction. In this manner, the NFC tag 114 can be manufactured withreduced size in a small form factor, and at a minimum cost.

The NFC tag 114 can store additional information (e.g., informationaside from identification information required for pairing) that can betransferred to the non-sterile computing device 150 via the NFCprotocol, including but not limited to a serial number, anidentification type/model/manufacturer of the sterile medical device110. The NFC tag 114 can store unique information that identifies anauthentic sterile medical device 110 over a counterfeit (possiblynon-sterile) device. Furthermore, the NFC tag 114 can be configured tostore information indicative of whether the sterile medical device 110has been previously used (e.g., information indicative of whethersterility has been breached). For example, the NFC tag 114 can beprogrammed with an inductive or capacitive flag that can be activatedonce the NFC tag 114 has been scanned with an NFC reader. In thismanner, the NFC tag 114 may provide an indication of whether or notsterility of the medical device has been compromised.

In the present disclosure, although NFC tag 114 is described as apassive tag which can be manufactured with reduced size in a small formfactor and at a minimum cost, it will be a matter of design choice toprovide the NFC tag 114 as an active tag, if desired. Similar to NFCpassive tags, a NFC active tag has an IC, an antenna and memory, but italso has an on board power supply and on board reader/writer circuit,which allows the NFC tag to actively broadcast signals and transferdata. NFC tags are manufactured in a variety of form factors andfunctional types. Although, most NFC tags communicate using the ISO14443 type A and B wireless standards over the 13.56 MHz NFCtransmission frequency, each type of NFC tag provides a differentstorage capacity and transfer speed. Tag types 1 and 2 come withcapacities between 48 bytes and 2 kilobytes of data, and can transmitthat information at 106 Kbps (kilo-bits-per-second). Type 3 NFC tags usethe Sony Felica standard, and can transfer data at 212 Kbps. Type 4 NFCtags have a larger memory capacity of up to 32 Kbytes and communicationspeeds of between 106 to a maximum of 424 Kbps. NFC tags types 1 and 2can be rewritten and reused, while types 3 and 4 are read only andcannot be rewritten.

<FIG. 3>

Turing now to FIG. 3, another pairing method is described. According toFIG. 3, a method of pairing a sterile medical device 110 with anon-sterile computing device 150 includes generating and writing steriledevice identifying information to the NFC tag 114 during manufacturing.

Specifically, according to the process illustrated in FIG. 3, at stepS301, during manufacture and/or assembly of the sterile medical device110, a non-illustrated NFC writer is configured to generate and writeidentification information into the NFC tag 114 of the sterile medicaldevice 110. As noted above, the NFC tag 114 may be programmed with aserial number, an identification type/model/manufacturer of the sterilemedical device 110, and/or identification information required forpairing.

Then, at step S302, when the sterile medical device 110 is scanned inits packaging 120 with the NFC transceiver 154 of the non-sterilecomputing device 150. At step 304, the non-sterile computing device 150will receive (read) this information and store it in its memory 156.During a medical procedure, once the sterile medical device 110 isunpackaged and turned on (step S306), the sterile medical device 110will read (S308) the information stored on its NFC tag 114 duringmanufacturing, and searches for a host (the non-sterile device). Oncethe host is found, sterile medical device 110 will start secure wirelesscommunications (S309) with the non-sterile computing device 150 over asecondary communication protocol such as Bluetooth or Direct WiFiutilizing the information previously stored in the NFC tag 114.

In this case, when the identification information is stored into the NFCtag 114 of the sterile medical device 110 during manufacture, it may bepossible that an authorized NFC reader may tamper with (read) thesterile medical device 110. To prevent such possibility, an embodimentof the present disclosure provides an added level of security.

<FIG. 4>

FIG. 4 illustrates an embodiment of a system for pairing a sterilemedical device 110 with a non-sterile computing device 150 withoutcompromising sterility of the sterile medical device. In the previousembodiment, if the sterile packaging 120 were accidentally orintentionally opened before the pairing procedure, the sterile medicaldevice 110 could not be paired with the non-sterile computing device 150without compromising sterility, which would render the sterile medicaldevice 110 potentially inoperable. In addition, if the NFC tag 114 wasread or written by an authorized NFC transceiver, the sterile medicaldevice 110 could not be paired with the non-sterile computing device150. The embodiment of FIG. 4, addresses these issues by embedding asecondary NFC tag 414 in the packaging 120 of the sterile medical device110.

More specifically, the embodiment illustrated in FIG. 4 is structurallysimilar to the system shown in in FIG. 1. However, in FIG. 4, the system100 includes a sterile medical device 110 enclosed in a sterilepackaging 120, wherein the sterile medical device 110 includes anembedded first NFC tag 114 (NFC TAG1), and the sterile packaging 120includes a second NFC tag 414 (NFC TAG2). All other aspects of thesystem 100 shown in FIG. 4 are the same as that of the system 100 shownin FIG. 1.

In FIG. 4, the first NFC tag 114 is non-removably embedded or integratedwith the sterile medical device 110. On the other hand, the second NFCtag 414 can be affixed to the packaging 120 (in the inside or outsidesurface), or it can be loose in the packaging 120, or it can be adetachable sticker removably affixed to the sterile medical device 110and fixedly attached to the packaging 120. If the second NFC tag 414 isembedded in the packaging 120 and at the same time connected or removalaffixed to the sterile medical device 110, when the sterile medicaldevice 110 is removed from the packaging 120, the second NFC tag 414remains attached to the packaging 120.

From henceforth the second NFC tag 414 may also be referred to as thepackaging NFC tag. In this embodiment the packaging NFC tag will be read(scanned) by the NFC transceiver 154 of non-sterile computing device150. To avoid that an authorized NFC reader may tamper with the sterilemedical device 110, the packaging NFC tag (the second NFC tag 414) andthe first NFC tag 114 can be programmed during device manufacture andmust contain the same specific identifying information of the sterilemedical device no. During device pairing, the NFC transceiver 158 of thenon-sterile computing device 150 will read the information stored in thesecond NFC tag 414 using the short-range NFC protocol; this allows thenon-sterile computing device 150 to establish a secure connection overanother wireless communication protocol such as Bluetooth, wirelesslocal area network (WLAN), or Direct WiFi.

Specifically, the non-sterile computing device 150 can employ knownauthorization/authentication methods to facilitate pairing with thesterile medical device 110 via NFC protocol. For example, duringmanufacturing, the NFC tag 114 can be programmed with identificationinformation that uniquely identifies the sterile medical device 110 tothe non-sterile computing device 150. During the pairing process, theNFC transceiver 154 can read (scan) the second NFC tag 414, and storethe read information in memory 156. Then, the non-sterile computingdevice 150 can compare the identification information read from the NFCtag 414 with identification information stored in NFC tag 114. Sinceinformation stored in NFC tag 114 will match the identificationinformation read from the NFC tag 414, the non-sterile computing device150 and the sterile medical device 110 can establish a securecommunication link over a long-range and high-speed communicationprotocol, such as Bluetooth or the like.

<FIG. 5>

FIG. 5 illustrates a method of pairing a sterile medical device 110 witha non-sterile computing device 150, as those shown FIG. 4, withoutcompromising sterility of the sterile medical device 110. In thisembodiment, at step S501, during manufacturing and/or assembly,identification information unique to the sterile medical device 110 isgenerated and written into both the first NFC tag 114 of the sterilemedical device 110 and into the second NFC tag 414 of the sterilepackaging 120. As discussed elsewhere in the disclosure, it is alsopossible to leave the first and second tags blank duringmanufacture/assembly, and then write pairing information from thenon-sterile computing device 150 into the first NFC tag 114 and thesecond NFC tag 414 at the time of first use in a medical operation. Atstep S502, in the event that the user may intentionally or accidentallybreak the sterile seal and separate the sterile medical device 110 fromits packaging 120, the sterile medical device 110 can preserve itssterility while the packaging 120 is used for pairing with thenon-sterile computing device 150. Specifically, at step S503, the NFCtransceiver 154 scans the second NFC tag 414 of the sterile packaging120. Then, at step S504, the NFC transceiver 154 reads the identifyinginformation from NFC tag 414, and stores the identification informationin memory 116.

The process of steps S504, S506, S508, and S509 are similar to thepreviously described steps S204, S206, S208, and S209 of FIG. 2.

In the present embodiment, the benefit offered by the second NFC tag 414is that the packaging tag does not need to remain sterile, and thus itcan be scanned in the non-sterile environment with the non-sterilecomputing device 150 even if the packaging of the sterile device isopened (accidentally or otherwise). Naturally, before opening thesterile packaging either NFC tag 114 of the sterile medical device 110or the second NFC tag 414 of the packaging 120 can be scanned with thecomputer to initiate wireless pairing. If the packaging 120 is openedbefore pairing, then the NFC tag 414 contained in the packaging can bebrought out of the sterile field and scanned with the non-sterilecomputer thus preserving the sterility of the sterile medical device110.

The first NFC tag 114 of the sterile medical device 110 could beeliminated completely and a duplicate of the identifying informationstored in the NFC tag 414 of the packaging 120 could be hard coded intothe memory 116 of the sterile medical device 110 as an alternativeembodiment. However, maintaining the two tags (a first NFC tag 114 and asecond NFC tag 414) has a major benefit in the device manufacturingprocess because this allows for the packaging NFC tag (the second NFCtag 414) to be programmed after the device is mated with itscorresponding sterile enclosure.

<FIG. 6>

FIG. 6 is a diagram of an exemplary system for preprogramming, duringmanufacturing, identification information into a NFC tag of the steriledevice and into a NFC tag of the sterile packaging. In FIG. 6, thesystem includes a manufacturing programming device 610 configured toprogram the first NFC tag 114 of the sterile medical device 110 and thesecond NFC tag 414 of the packaging 120. To that end, the manufacturingprograming device 610 includes a processor 612, a memory 616, a userinterface 613, and a NFC writer 617. In this case, the manufacturingprogramming unit 610 uses the NFC writer 617 to program (write into)both the sterile device NFC tag 114 and the packaging NFC tag 414 withthe same (duplicate) identification information IDX1. The processor 612,memory 616 and user interface 613 are similar to processor 152, memory156 and user interface 153, respectively, of the non-sterile device 150.

<FIG. 7>

FIG. 7 is a diagram of an exemplary system for duplicatingidentification information preprogrammed in the NFC tag 114 of thesterile medical device 110 onto the NFC tag 414 of the sterile packaging120. In FIG. 7, it is assumed that the sterile medical device no haspreviously generated and stored identifying information alreadyprogrammed into its NFC tag 114. This could occur during themanufacturing of sterile medical device no, or during functional testingthereof, for example. In this case, during assembly (mating) of thesterile medical device no with its packaging 120, the manufacturingprogramming device 610 reads the NFC tag 114 (NFC tag 1) of sterilemedical device no to extract the identifying information already storedtherein, and duplicates such information onto the packaging NFC tag 414.More specifically, as shown in Fig. 7, the NFC reader 718 of themanufacturing programming device 610 reads identification information(IDXa) from the NFC tag 114. Then, the NFC writer 617 writes the sameidentification information (IDXa) into the NFC tag 414 of the packaging120.

Both methods shown in FIGS. 6 and 7 allow for the packaging NFC tag (NFCtag 114) to be programmed during or after the sterile medical device nois mated with its corresponding packaging 120. The benefit of programingthe NFC tag 114 and the NFC tag 414 with the same information is thereduced risk of mismatch between the sterile device NFC tag and thepackaging NFC tag. Since NFC tags 114 and 414 work under wireless nearfield technology, the tags can be programmed after the packaging issealed, and if desired even after the device has been sterilized.

When the NFC tags are programmed during device manufacture, theinformation contained on the NFC tag could be available to be readand/or tampered with by a nefarious user (man-in-the-middle), e.g.,during device transport to a medical facility. A nefarious user couldutilize the information contained on the NFC tags to perform aman-in-the-middle (MITM) attack of the wireless communication betweenthe devices. The pairing process of FIG. 2 is more secure since theidentifying information is only written to the NFC tag when the deviceis ready to be used. Embodiment 3 is a method of embodiment 2 coupledwith additional security enhancements to prevent MITM attacks.

<FIG. 8>

FIG. 8 illustrates a system and method in which the NFC tag 414 of thepackaging 120 and the NFC tag 114 of the sterile medical device 110 areeither password protected and/or pre-encrypted. Specifically, as shownin FIG. 8, during a medical procedure, the packaging 120 is firstseparated from the sterile medical device no intentionally or otherwise.The NFC tag 414 (NFC TAG2) of the packaging 120 includes a memory 802which has been preprogrammed with a password and/or an encryption key(identifying information 804).

To initiate sterile device use (during a medical procedure), the NFCtransceiver 154 of the non-sterile computing device 150 will communicatethe identifying information (password/key) to the NFC tag 414, by a NFCwrite command 825. In this manner, the NFC tag identifying information804 is unlocked for reading by the non-sterile device 150 via a NFC readcommand 826. This process makes the sterile medical device no moresecure because a nefarious user would require knowledge of thispreprogrammed password/key in order to read the information contained onthe NFC tag 414 of the packaging 120. Thus, preprograming the NFC tag414 with identifying information 804 provides an additional layer ofsecurity.

Alternatively, the method includes adding identifying information storedon the NFC tags pre-encrypted with a common (the same) key (e.g., asshown in FIG. 6). To that end, it is preferable that the manufacturerhas control over the programming of both the sterile medical device 110and non-sterile device 150, so that the manufacturer can implement aproprietary encryption algorithm on both devices. When theidentification information stored in the NFC tags is read by thenon-sterile device, the identifying information could be decrypted withthe pre-stored key, and then the decrypted information will be used tosecure wireless communications between the sterile device and thenon-sterile device. A nefarious user would be required to reverseengineer the encryption algorithm contained on the sterile ornon-sterile device to perform a MITM attack of the wirelesscommunications. However, in order to practice this method, the sameprogramming (preferably by the same manufacturer) would need to be doneon both sterile and non-sterile devices so that both devices know thecorrect key to negotiate secure communications.

Lastly, a higher security method of pairing a sterile medical device toa non-sterile computing device would combine the method of using apassword with the method of using an encryption key. A combinationmethod for higher security includes storing a pre-encrypted key on bothNFC tags (i.e., in the first NFC tag 114 and in the second NFC tag 414).In addition, the combination method includes providing a common password(the same password) that would unlock both NFC tags (i.e., in the firstNFC tag 114 and in the second NFC tag 414). In this manner, the NFC tagsare both encrypted with a key, and password protected. In thiscombination method the non-sterile device 150 would transmit a passwordto the NFC tag 414 thus unlocking its contents to be read. Thenon-sterile device 150 would then read the pre-encrypted key from theNFC tag 114 of the sterile medical device 110. The pre-encrypted keywould then be run through a proprietary decryption algorithm to discoverthe actual key that will be used to encrypt wireless communications.Since this method provides several layers of security it can beconsidered the maximum security method to practice while still maintainthe sterility of the sterile medical device.

This disclosure has the following advantages over conventional art. Allof the embodiments allow for secure out-of-band pairing of a steriledevice to a non-sterile device without compromising sterility of thesterile device. One or more embodiments provides a mode for programmingsterile devices after they are mated with their packaging and sterilizedin manufacturing reducing the risk of mismatch of packaging and device.One or more embodiments provide additional security measures to reducethe risks of unauthorized usage, MITM attacks, and/or tampering ofsterile medical devices.

A novel system and methods for out-of-band pairing of a sterile deviceto a non-sterile device are disclosed. In one aspect, the sterile deviceis provided with an embedded NFC tag; the NFC tag and the sterile deviceare enclosed in a sterile package. A secondary NFC tag is provided inthe sterile packaging of sterile medical device. This enables pairingthe sterile device with a non-sterile device even after the sterilebarrier packaging is opened, but without compromising the sterility ofthe sterile device. According to one aspect, a method includesprogramming of the packaging NFC tag and sterile device NFC tag afterthe sterile device is mated and sealed with its package and sterilized.This allows for the programming to be performed with custom processes oralgorithms by entities other than the manufacturer.

At least one embodiment includes the above features plus passwordprotected NFC memory for added security. At least one embodimentincludes the above features plus pre-encoded wireless device informationand encryption key for additional security to further reduce theprobability of MITM attacks. At least one embodiment includes the abovefeatures plus password protected NFC memory and pre-encoded wirelessdevice information and encryption key.

Thus far, the disclosure has described various aspects of pairing asterile device with a non-sterile device for wireless communications.Several environments to practice the various novel aspects are includedherein.

<FIG. 9>

FIG. 9 is a diagram of an exemplary system for pairing a sterilepercutaneous needle guidance device with a non-sterile computer withoutbreaking sterility of the sterile percutaneous needle guidance device.In the example of FIG. 9, a sterile medical device 110 needs to pair andcommunicate with a non-sterile computing device 150. The sterile medicaldevice 110 includes, for example, a sterile guidance device 902 and asterile communication unit (CU) 910. The non-sterile computing device150 includes, for example, a computer or system console equipped with awireless communication transceiver 158 (e.g., a WiFi router or accesspoint), a near-field or NFC transceiver 154, and a display device 153.The display device 153 can be a touchscreen liquid crystal display (LCD)which displays images and medical operations on a graphical userinterface (GUI) 155.

The sterile guidance device 902 is a sterile needle-guiding instrumentwhich includes or is connected to the communication unit (CU) 910. Thecommunication unit 910 and/or the guidance device 902 have an embeddedNFC tag 114 (at least one first NFC tag). Prior to use in a medicalprocedure, this guidance device 902 and communication unit 910 arepackaged in a sterile packaging 120. The packaging 120, in turn, alsocontains an attached or embedded NFC tag 414 (a second NFC tag). The NFCtag 414 contains identification information which is a duplicate ofidentification information contained in the NFC tag 114 of the sterilemedical device 110. Before opening the sterile packaging 120 either thefirst or second NFC tag (114 or 414) can be scanned with the NFCtransceiver 154 of the non-sterile computer device 150 to initiate OOBpairing using a NFC signal 125 under NFC communication protocol (referto FIG. 10A). After pairing, the sterile packaging 120, which stillcontains the sterile medical device is moved to the sterile field andopened (as shown in FIG. 10B) to prepare the guidance device 902 andcommunication unit 910 for use (refer to FIG. 10C-FIG. 10D). If thepackaging 120 is first opened in the sterile field (e.g., operatingroom) before pairing, then the NFC tag 414 contained in the now emptypackaging 120 can be brought out of the sterile field (see arrow 913 inFIG. 9), and scanned with the NFC transceiver 154 of the non-sterilecomputer device 150 thus preserving the sterility of the guidance device902 and of the communication unit 910. Upon reading the NFC tag 414 bythe NFC transceiver 154, the non-sterile device 150 stores theidentification information in its memory 156. When the sterile medicaldevice 110 is powered ON, communication unit 910 reads information fromthe NFC tag 114 and searches for a host device (non-sterile device 150).Since the host device can confirm the identification information of NFCtag 114, the communication unit 910 establishes a secure connection withthe wireless transceiver 158 of the non-sterile computing device 150 viaa wireless signal 135 under a communication protocol other than the NFCprotocol, e.g.., Bluetooth or Direct WiFi or other similar longer rangecommunication protocol.

<FIG. 10>

FIG. 10A through FIG. 10E show exemplary GUI prompts for guiding a userto perform a process of pairing a sterile percutaneous needle guidancedevice with a non-sterile computer without breaking sterility of thesterile percutaneous needle guidance device. As shown in FIG. 10A, priorto initiating a medical procedure which requires the use of a sterilemedical device 110, the system console or non-sterile computer device150 can be configured to prompt a user, via the GUI 155, to scan thesterile medical device 110 (in this case a needle guide device) using areader (e.g., NFC transceiver 154) attached to the computer device 150.Here, the system console or computer device 150 can be programmed toprompt the user to move or place the packaged sterile medical device ina specific manner (e.g., at a specific position, distance, ororientation) until the sterile medical device is effectively scanned bythe console reader.

As shown in FIG. 10B, the computer device 150 can be further programmedto prompt the user to open the device page, and place the sterile devicecomponents on a safe environment of the sterile field (e.g., a steriletable). As shown in FIG. 10C, the computer device 150 can be furtherconfigured to prompt and instruct the user, via the GUI 155, how toactivate (turn ON) the sterile medical device 110. As explained earlier,when the sterile medical device 110 is activated (turned ON), thecommunication unit 910 reads identification information from the NFC tag114, and starts searching for a host device (non-sterile device). Heretoo, in the case that the sterile medical device 110 does not find ahost device, the computer device 150 can be programmed to prompt theuser, via the GUI 155, to move or reposition the unpackaged sterilemedical device 110 in a specific manner (e.g., at a specific position,distance, or orientation) until the sterile medical device 110establishes reliable wireless communication with the non-sterilecomputing device 150.

FIG. 10D and FIG. 10D illustrate the advantageous result of providingguided prompts to the user during the un-packaging and pairing of thesterile and non-sterile medical devices. Specifically, as shown in FIG.10D, the GUI 155 presents the user with a graphical guide of positionand connection strength between the non-sterile device 150 and thesterile medical device 110. Finally, FIG. 10E shows a graphicalillustration of successful positioning, pairing, and connection betweenthe sterile medical device 110 and the non-sterile device 150. Inaddition, in the event that there is a suspicion of tampering or loss ofsterility, the computer or system console can be programmed to promptthe user (e.g., by issuing a warning) that the sterile medical device110 should be discarded and replaced by a new one.

<FIG. 11>

FIG. 11 illustrates a further process (method) for out-of-band pairingsterile to non-sterile devices without compromising sterility thereof.The process of FIG. 11 is an interactive pairing process in which a user(e.g., a physician or technician) can be guided by prompts and imagingoutput by the GUI 155 of the non-sterile computing device 150 (shown inFIG. 9). For the process of FIG. 11, it is assumed an environment wherethe non-sterile computing device 150 is a console or workstationconnected to a NFC reader located in a non-sterile field (e.g., acontrol room). The sterile medical device 110 is a needle guide deviceenclosed in a sterile packaging 120. The sterile medical device no needsto be paired with the non-sterile device 150 without compromisingsterility.

According to FIG. 11, at step S602, the GUI 155 outputs an image asshown in FIG. 10A with a prompt instructing the user to place thesterile device with its packaging and NFC tag(s) in close proximity tothe non-sterile device reader. At step S602, the non-sterile device 150determines whether the tag(s) attached to the packaging or the steriledevice has been properly scanned by the reader. As explained elsewherein this disclosure, the non-sterile device 150 can either write pairinginformation into, or it can read pairing information from, at least oneof the first NFC tag or the second NFC tag. In a case where at least oneof the tag(s) is not properly scanned (NO at S604), the non-steriledevice 150 can prompt the user to move the sterile device closer to theNFC reader, at step S606. Here, it should be recalled that the NFC tagsare read using a short-range wireless communication protocol (e.g., theNFC protocol). The process of S602, S604, and S606 can be repeated a fewtimes until at least one of the tags is scanned. If scanning of the tagsfails, the processor of non-sterile device 150 can be programmed toprompt the user to replace the sterile device (i.e., to use adifferent/new sterile device) until at least one of the tags is properlyscanned.

Once at least one of the tags is scanned (YES at S604), the processadvances to step S608. Successful scanning of at least one of the tagsmay include reading the information stored in the second NFC tag 414 (orfirst NFC tag 114). Since both tags are preferably programmed with thesame pairing information, either of the tags can be scanned. Therefore,the use of the two tags facilitates ease and speed of scanning. At stepS608, the processor of non-sterile device 150 prompts the user to carry,move, or place the sterile medical device 110 with its sterile packaging120 and the corresponding NFC tags into the sterile field (e.g., theoperating room). At step S610, the GUI 155 may prompt the user to openthe packaging 120, remove the sterile medical device 110, and place thesterile components of sterile medical device 110 on a sterile surface(see FIG. 10B). At this time, the user may be prompted activate (turnON) the sterile medical device 110, as shown in FIG. 10C. At step 5612,the sterile medical device 110 reads pairing information from its NFCtag (TAG1) and searches for a host device (the non-sterile device), bybroadcasting a connection request. Here, since the non-sterile device150 has stored the information scanned at steps S602-S604, the processorof sterile device 150 can grant/accept the connection request receivedfrom the sterile medical device 110.

At step S614, the processor of non-sterile device 150 (or thecommunication unit 910 of the sterile medical device 110) can determinewhether a connection between the sterile medical device 110 and thenon-sterile device 150 has been established. If connection between thesterile medical device 110 and non-sterile device 150 is confirmed (YESat S614), the process advances to step S620. At step S620, the steriledevice located in the sterile field and the non-sterile device locateoutside of the sterile field are fully enabled to communicate via asecure wireless connection using a long-range wireless protocol (e.g.,Bluetooth or WiFi) other than the short-range wireless protocol.Therefore, at step S620, the GUI 155 may inform the user that thesterile medical device no and non-sterile device 150 have beensuccessfully paired to each other (see FIG. 10E)

At step S614, the processor of non-sterile device 150 could determinethat a connection between the sterile medical device no and thenon-sterile device 150 has not been established or cannot be established(NO at S614). There could be various reasons that may precludeestablishing a connection between the sterile medical device no and thenon-sterile device 150 even after at least one of the NFC tags has beenscanned. For example, prior to starting the medical procedure, if thenon-sterile device 150 or its transceiver accidently loses power orbecomes disconnected, a connection could not be confirmed at step S614.Also, after powering ON, the sterile medical device no may undergo aself-test procedure. If the self-test procedure fails, it may be helpfulto rescan the NFC tag of the packaging 120 with the non-sterile device150 before discarding the sterile medical device 110. In either of thesescenarios, the sterile device may remain in the sterile field (S616),while the user may be prompted (at step S618) to use the packaging 120and the second NFC tag 414 to repeat the scanning step without removingthe sterile device from the sterile field.

In another example a non-sterile dialysis machine needs to be pairedwith a sterile dialysis accessory such as a blood pressure monitor. Inthis example the dialysis accessory has an RFID or NFC tag embedded inthe device and the sterile packaging containing the dialysis accessoryhas a duplicate NFC or RFID tag. Before breaking the sterile barriereither tag can be read by the non-sterile dialysis machine. After thepackage is opened, sterility of the dialysis accessory can be maintainedby scanning only the packaging tag on the non-sterile dialysis machine.

Many medical devices require a sterilized component capable of extendinginto a sterile field, without risk of contaminating that field, wherethat sterile component interfaces with an unsterile component needed tooperate the device. In this situation, the unsterile component canpotentially enter the sterile field and negate the sterility of thatfield. A solution to prevent loss of sterility has been to deploy asterile barrier over any unsterile component entering the sterile field.This especially applies to medical devices used in in-vivo environments,where sterile components such as interventional robotic systems thatmust interface with an electronic component which cannot be sterilized.

For example a non-sterile computer needs to be paired with a sterilecontroller for guiding a surgical robot. The controller must maintainsterility since the doctor will use the controller with his or hersterile gloves for guiding a surgical robot. According to the presentdisclosure, the controller contains an embedded NFC or RFID tag and thecontroller in enclosed in a sterile drape or packaging. In this casetoo, the controller's sterile drape of packaging also contains aduplicate NFC or RFID tag. During a procedure, the doctor ortechnologist can scan either tag (the controller tag or the packagingtag) before the sterile packaging is opened. However, in the case thatthe packaging is opened before pairing, the duplicate tag in thepackaging allows the physician or technologist to still pair the sterilecontroller with the non-sterile computer without breaking sterility ofthe controller.

These are only a few examples of the many possible applications in whichthe present disclosure can be practiced. Those skilled in the art willappreciate that there are many other aspects under which the presentdisclosure may be practiced.

According to a first aspect (aspect 1) the present disclosure can bepracticed as a system for out-of-band pairing sterile and non-steriledevices without compromising sterility thereof, the system comprising: asterile medical device; a non-sterile device; a sterile packagingenclosing at least the sterile medical device; at least one NFC tagconfigured to store identifying information of the sterile medicaldevice; a NFC transceiver configured to communicate with the NFC tag viaa first wireless protocol; and a processor and a memory coupled to theprocessor, the memory storing instructions executable by the processorto: receive a pairing request signal from the sterile medical devicelocated inside a sterile field; transmit the pairing request signal tothe non-sterile device located outside the sterile field; and wherein,in response to receiving the pairing request signal, the processorconfigures the sterile medical device to use the identifying informationstored in the at least one NFC tag to wirelessly connect with thenon-sterile device via a second wireless protocol which is differentfrom the first wireless protocol.

According to a second aspect (aspect 2) the present disclosure can bepracticed as the system of aspect 1, wherein the non-sterile deviceincludes the NFC transceiver, wherein the NFC transceiver is configuredto write the identifying information into the at least one NFC tag, andwherein the sterile medical device includes a NFC reader configured toread the identifying information from the at least one NFC tag.

According to a third aspect (aspect 3) the present disclosure can bepracticed as the system of aspect 1, wherein the at least one NFC tag isintegrated into the sterile medical device, and wherein the identifyinginformation includes a wireless identifier and/or encryption key whichserves to associate the sterile medical device with the non-steriledevice.

According to a fourth aspect (aspect 4) the present disclosure can bepracticed as the system of aspect 1, wherein the at least one NFC tagincludes an RFID tag integrated into the sterile medical device.

According to a fifth aspect (aspect 5) the present disclosure can bepracticed as the system of aspect 1, wherein the at least one NFC tagincludes a first NFC tag integrated into the sterile medical device anda second NFC tag integrated into the sterile packaging.

According to a sixth aspect (aspect 6) the present disclosure can bepracticed as the system of aspect 5, wherein the non-sterile device isconfigured to write the identifying information into both the first NFCtag and the second NFC tag, and the sterile medical device is configuredto read the identifying information from the first NFC tag, and whereinthe non-sterile device and the sterile medical device use theidentifying information read from the first NFC tag to wirelesslyconnect with each other, in response to receiving the pairing requestsignal.

According to a seventh aspect (aspect 7) the present disclosure can bepracticed as the system of aspect 6, wherein the sterile medical deviceincludes one or more of a needle guidance device, a sterile dialysismachine, and a sterile controller for guiding a surgical robot.

According to an eighth aspect (aspect 8) the present disclosure can bepracticed as the system of aspect 1, wherein the at least one NFC tagincludes an antenna, an integrated circuit, and a memory which stores apassword protected wireless encryption key, wherein the non-steriledevice includes a NFC transceiver configured to transmit an unlockingpassword to the at least one NFC tag, and wherein, in response toreceiving the unlock password, the at least one NFC tag transmits thewireless encryption key to the non-sterile device.

According to a ninth aspect (aspect 9) the present disclosure can bepracticed as the system of aspect 5, further comprising: a manufacturerprogramming unit configured to program the first and second NFC tagswith an encryption key after the sterile medical device has beenenclosed with the sterile packaging, thus eliminating risk of keymismatch between the first NFC tag and the second NFC tag.

According to a ninth(b) aspect (aspect 9b) the present disclosure can bepracticed as the system of aspect 3, further comprising: a manufacturerprogramming unit configured to program the at least one NFC tagintegrated in the sterile medical device with an encryption key afterthe sterile medical device has been enclosed with the sterile packaging,wherein the encryption key serves to associate the sterile medicaldevice with the non-sterile device thus eliminating risk of key mismatchbetween the sterile medical device and non-sterile device. According tothis aspect (aspect 9b), when the sterilization process would include arisk to damage or breaking some sensitive parts of the sterile device,or a risk to fail sterilization, it would be advantageous if we cancomplete a definition process of the encryption key after thesterilization process. This would reduce risk to do unnecessarymanufacturing steps, and would ensure proper sterilization and pairingsecurity.

According to a tenth aspect (aspect 10), the present disclosure can bepracticed as the system of aspect 5, wherein both the first NFC tag andthe second NFC tag are configured with identical identificationinformation, wherein, before opening of the sterile packaging, eitherthe first NFC tag or the second NFC tag is scanned with a scanner of thenon-sterile device to initiate wireless pairing, and wherein, afteropening of the sterile packaging, only the second NFC tag integratedwith the sterile packaging is scanned with the scanner to initiatewireless pairing.

According to an eleventh aspect (aspect 11), the present disclosure canbe practiced as a method for out-of-band pairing sterile and non-steriledevices without compromising sterility thereof, the method comprising:forming a communication system comprising: a sterile medical deviceintegrated with a first near field communication (NFC) tag; anon-sterile device; and a sterile packaging integrated with a second NFCtag and enclosing the sterile medical device and the first NFC tag,storing identical identification information in the first NFC tag and inthe second NFC tag; and scanning the first NFC tag or the second NFC tagwith the non-sterile device according to a status of the sterilepackaging, wherein, before opening of the sterile packaging, either thefirst NFC tag or the second NFC tag is scanned with the non-steriledevice to initiate wireless pairing, and wherein, after opening of thesterile packaging, only the second NFC tag integrated in the sterilepackaging is scanned with the non-sterile device to initiate wirelesspairing.

According to a twelfth aspect (aspect 12), the present disclosure can bepracticed as the method of aspect 11, further comprising: writing theidentical identifying information into both the first NFC tag and thesecond NFC tag before the opening of the sterile packaging.

According to a thirteenth aspect (aspect 13), the present disclosure canbe practiced as the method of aspect 11, further comprising: afteropening of the sterile packaging, transmitting the identificationinformation from the second NFC tag to the non-sterile device toinitiate the wireless pairing.

According to a fourteenth aspect (aspect 14), the present disclosure canbe practiced as the method of aspect 11, wherein the identifyinginformation includes a wireless identifier and an encryption key whichserves to enable wireless communication between the sterile medicaldevice and the non-sterile device.

According to a fifteenth aspect (aspect 15), the present disclosure canbe practiced as the method of aspect 11, wherein the non-sterile deviceis configured to write the identifying information into both the firstNFC tag and the second NFC tag, and the sterile medical device isconfigured to read the identifying information from the first NFC tag,and wherein the non-sterile device and the sterile medical device usethe identifying information read from the first NFC tag to wirelesslyconnect with each other, in response to a received pairing requestsignal.

According to a sixteenth aspect (aspect 16), the present disclosure canbe practiced as the method of aspect 11, wherein the sterile medicaldevice includes one or more of a needle guidance device, a steriledialysis machine, and a sterile controller for guiding a surgical robot,and wherein the pairing includes pairing at least one of the needleguidance device, the sterile dialysis machine, and the sterilecontroller for guiding a surgical robot with the non-sterile medicaldevice for secure wireless communication.

According to a seventeenth aspect (aspect 17), the present disclosurecan be practiced as the method of aspect 11, wherein the first NFC tagand the second NFC tag are configured with a password protected wirelessencryption key, wherein the non-sterile device includes a NFCtransceiver configured to transmit an unlocking password to at least oneof the first and second NFC tag, and wherein, in response to receivingthe unlock password, the at least one of the first and second NFC tagtransmits the encryption key to the non-sterile device.

According to an eighteenth aspect (aspect 18), the present disclosurecan be practiced as the method of aspect 11, further comprising:programming the first and second NFC tags with an encryption key afterthe sterile medical device has been enclosed with the sterile packaging,thus eliminating risk of key mismatch between the first NFC tag and thesecond NFC tag.

According to a nineteenth aspect (aspect 19), the present disclosure canbe practiced as the method of aspect 11, wherein both the first NFC tagand the second NFC tag are configured with identical identificationinformation, wherein, before opening of the sterile packaging, eitherthe first NFC tag or the second NFC tag is scanned with the non-steriledevice to initiate wireless pairing, and wherein, after opening of thesterile packaging, only the second NFC tag integrated in the sterilepackage is scanned with the non-sterile device to initiate wirelesspairing.

According to a twentieth aspect (aspect 20), the present disclosure canbe practiced as a method for out-of-band pairing sterile and non-steriledevices without compromising sterility thereof, the method comprisingthe steps of: (a) forming a communication system comprising: a sterilemedical device, a non-sterile device, a sterile packaging enclosing atleast the sterile medical device, at least one NFC tag integrated withthe sterile medical device and storing identifying information about thesterile medical device, and a NFC transceiver operatively connected tothe non-sterile device and configured to communicate with the at leastone NFC tag via a first wireless protocol; (b) during a pairing process,scanning the at least NFC tag with the NFC transceiver and exchangingpairing information via the first wireless protocol; and (c) during amedical procedure: (c1) activating the at least one NFC tag, and (c2)transmitting a connection request from the sterile medical devicelocated inside a sterile field to the non-sterile device located outsidethe sterile field, wherein the sterile medical device uses the pairinginformation and the identifying information stored in the at least oneNFC tag to wirelessly connect with the non-sterile device via a secondwireless protocol which is different from the first wireless protocol.

According to a twenty first aspect (aspect 21) the present disclosurecan be practiced as the method of aspect 20, wherein, during the pairingprocess, the step of exchanging pairing information via the firstwireless protocol includes programming the at least one NFC tagintegrated in the sterile medical device with an encryption key afterthe sterile medical device has been enclosed with the sterile packaging,wherein the encryption key serves to associate the sterile medicaldevice with the non-sterile device thus eliminating risk of key mismatchbetween the sterile medical device and non-sterile device.

According to a twenty second aspect (aspect 22), the present disclosurecan be practiced as a system for out-of-band pairing sterile andnon-sterile medical devices without compromising sterility thereof, thesystem comprising: a sterile medical device; a non-sterile device; atleast one near field communication (NFC) tag configured to storeinformation about of the sterile medical device; and a processor coupledto a memory which stores instructions executable by the processor to:prompt a user to place the at least one NFC tag within close proximityof the non-sterile device, establish a first wireless connection betweenthe non-sterile medical device and the at least one NFC tag fortransmitting the information about of the sterile medical device fromthe NFC tag to the non-sterile medical device, and establish a secondwireless connection between the sterile medical device located inside asterile field and the non-sterile device located outside the sterilefield for exchanging operational information between the sterile medicaldevice and the non-sterile device, wherein the processor establishes thesecond wireless connection based on the information about the sterilemedical device read from the NFC tag, and wherein the processorestablishes the first wireless connection for transmitting the pairinginformation between the at least NFC tag and the non-sterile medicaldevice over a NFC protocol, and establishes the second wirelessconnection for exchanging operational information between the sterilemedical device and the non-sterile device over a short or long rangewireless communication protocol different from the NFC protocol.

In describing the exemplary embodiments illustrated in the drawings,specific terminology is employed for the sake of clarity. However, thedisclosure of this patent specification is not intended to be limited tothe specific terminology so selected and it is to be understood thateach specific element includes all technical equivalents that operate ina similar manner.

Therefore, while the present disclosure has been described withreference to exemplary embodiments, it is to be understood that thepresent disclosure is not limited to the disclosed exemplaryembodiments. The scope of the following claims is to be accorded thebroadest reasonable interpretation so as to encompass all suchmodifications and equivalent structures and functions.

What is claimed is:
 1. A system, comprising: a host device; a medicaldevice enclosed in a sterile packaging and configured to wirelesslyconnect to the host device; at least one electronic tag attached to thesterile packaging and/or attached to the medical device, the at leastone electronic tag configured to store pairing information necessary forestablishing a wireless connection between the medical device and thehost device; and a processor configured to: control a first wirelesscommunication of the host device with the at least one electronic tagusing a first wireless protocol; control a second wireless communicationof the medical device with the at least one electronic tag using thefirst wireless protocol; and control a third wireless communication ofthe medical device with the host device using a second wireless protocoldifferent from the first wireless protocol, wherein, in the firstwireless communication, the processor controls the host device to writepairing information into the at least one electronic tag using the firstwireless protocol; wherein, in the second wireless communication, theprocessor controls the medical device to read pairing information fromthe at least one electronic tag using the first wireless protocol, andwherein, in the third wireless communication, the processor controls themedical device to establish a secure wireless connection with the hostdevice using the pairing information read from the at least oneelectronic tag using the second wireless protocol.
 2. The systemaccording to claim 1, wherein the host device includes a near fieldcommunication (NFC) transceiver, and the first wireless communicationprotocol is a NFC protocol, wherein the at least one electronic tagincludes one NFC tag connected to both the medical device and thesterile packaging.
 3. The system according to claim 2, wherein theprocessor controls the NFC transceiver of the host device to write thepairing information into the one NFC tag using the NFC protocol, andwherein the pairing information includes one or more of a wirelessidentifier, an encryption key, and a password which serves to associatethe medical device with the host device for secure communication witheach other.
 4. The system according to claim 3, wherein the medicaldevice is configured to read the pairing information from the one NFCtag, and transmit a pairing request signal to the host device using thesecond wireless protocol, and wherein, in response to receiving thepairing request signal, the processor controls the host device toestablish a secure wireless connection with the medical device using thepairing information read from the one NFC tag.
 5. The system accordingto claim 3, wherein the medical device is configured to read the pairinginformation from the one NFC tag, and transmit a pairing request signalto the host device using the second wireless protocol, and wherein, in acase of not receiving the pairing request signal, the processor controlsthe host device to prompt a user to place the sterile package with theone NFC tag in close proximity to the NFC transceiver, wherein theprocessor controls the NFC transceiver to read the pairing informationfrom the one NFC tag using the NFC protocol, and wherein the processorcontrols the host device to establish a secure wireless connection withthe medical device using the pairing information read from the one NFCtag.
 6. The system according to claim 1, wherein the host deviceincludes a near field communication (NFC) transceiver, and the firstwireless communication protocol is a NFC protocol, wherein the at leastone electronic tag includes a first NFC tag integrated into the medicaldevice and a second NFC tag provided with the sterile packaging, andwherein the medical device and the first NFC tag are contained insidethe sterile packaging.
 7. The system according to claim 6, wherein theprocessor controls the NFC transceiver to write the pairing informationinto both the first NFC tag and the second NFC tag using the NFCprotocol, while the medical device and the second NFC tag are containedinside the sterile packaging, and wherein the pairing informationincludes one or more of a wireless identifier, an encryption key, and apassword which serves to associate the medical device with the hostdevice for secure communication with each other.
 8. The system accordingto claim 7, wherein the medical device is configured to read the pairinginformation from the first NFC tag integrated into the medical device,and transmit a pairing request signal to the host device using thesecond wireless protocol, and wherein, in response to receiving thepairing request signal, the processor controls the host device toestablish the wireless connection with the medical device using thepairing information read from the first NFC tag.
 9. The system accordingto claim 7, wherein the medical device is configured to read the pairinginformation from the first NFC tag integrated into the medical device,and transmit a pairing request signal to the host device using thesecond wireless protocol, wherein, in a case of not receiving thepairing request signal, the processor controls the host device to prompta user to place the second NFC tag integrated into the sterile packagingin close proximity to the NFC transceiver, wherein the processorcontrols the NFC transceiver to read the pairing information from thesecond NFC tag using the NFC protocol, and wherein the processorcontrols the host device to establish a secure wireless connection withthe medical device using the pairing information read from the secondNFC tag.
 10. The system according to claim 1, wherein the host deviceincludes a near field communication (NFC) transceiver, the at least oneelectronic tag includes a first NFC tag coupled to the medical deviceand a second NFC tag coupled to the sterile packaging, and the firstwireless communication protocol is a NFC protocol, wherein the processoris further configured to: prompt a user to place the medical deviceenclosed in the sterile packaging in a first location in close proximityto the NFC transceiver of the host device, control the NFC transceiverof the host device to scan at least one of the first NFC tag and thesecond NFC tag using the NFC protocol, and prompt the user to place themedical device enclosed in the sterile packaging in second location awayfrom the host device, remove the medical device from the sterilepackaging, and turn ON the medical device to establish a secure wirelessconnection with the host device using the second wireless protocol. 11.The system according to claim 1, wherein the host device includes a nearfield communication (NFC) transceiver, the at least one electronic tagincludes a first NFC tag coupled to the medical device and a second NFCtag coupled to the sterile packaging, and the first wirelesscommunication protocol is a NFC protocol, wherein the first NFC tag andsecond NFC tag each includes a password-protected encryption key,wherein, in the first wireless communication, the processor controls theNFC transceiver of the host device to transmit an unlocking password toat least one of the first and second NFC tags using the NFC protocol,wherein, in the second wireless communication, the medical device usesthe unlocking password to read the encryption key from the at least oneof the first and second NFC tags using the NFC protocol, and wherein, inthe third wireless communication, the medical device transmits theencryption key to the host device, and based on the encryption key, thehost device establishes a secure wireless connection with the medicaldevice using the second wireless protocol.
 12. A method, comprising:enclosing a medical device in a sterile packaging; attaching at leastone electronic tag to the sterile packaging and/or to the medicaldevice, the at least one electronic tag configured to store pairinginformation necessary for establishing a wireless connection between themedical device and a host device; causing a processor to executeoperations that comprise: controlling a first wireless communication ofthe host device with the at least one electronic tag using a firstwireless protocol; controlling a second wireless communication of themedical device with the at least one electronic tag using the firstwireless protocol; and controlling a third wireless communication of themedical device with the host device using a second wireless protocoldifferent from the first wireless protocol, wherein, in the firstwireless communication, the processor controls the host device to writepairing information into the at least one electronic tag using the firstwireless protocol; wherein, in the second wireless communication, theprocessor controls the medical device to read pairing information fromthe at least one electronic tag using the first wireless protocol, andwherein, in the third wireless communication, the processor controls themedical device to establish a secure wireless connection with the hostdevice using the pairing information read from the at least oneelectronic tag using second wireless protocol.
 13. The method accordingto claim 12, wherein the host device includes a near field communication(NFC) transceiver, and the first wireless communication protocol is aNFC protocol, wherein attaching the at least one electronic tag includesattaching one NFC tag to both the medical device and the sterilepackaging.
 14. The method according to claim 13, further comprising:controlling the NFC transceiver of the host device to write the pairinginformation into the one NFC tag using the NFC protocol, wherein thepairing information includes one or more of a wireless identifier, anencryption key, and a password which serve to associate the medicaldevice with the host device for secure communication with each other.15. The method according to claim 14, further comprising: the medicaldevice reading the pairing information from the one NFC tag using theNFC protocol, and transmitting a pairing request signal to the hostdevice using the second wireless protocol, wherein, in response toreceiving the pairing request signal, the processor controls the hostdevice to establish a secure wireless connection with the medical deviceusing the pairing information read from the one NFC tag.
 16. The methodaccording to claim 14, further comprising: the medical device readingthe pairing information from the one NFC tag using the NFC protocol, andtransmitting a pairing request signal to the host device using thesecond wireless protocol, and wherein, in a case of not receiving thepairing request signal, the processor controls the host device to prompta user to place the sterile package with the one NFC tag in closeproximity to the NFC transceiver, wherein the processor controls the NFCtransceiver to read the pairing information from the one NFC tag usingthe NFC protocol, and wherein the processor controls the host device toestablish a secure wireless connection with the medical device using thepairing information read from the one NFC tag.
 17. The method accordingto claim 12, wherein the host device includes a near field communication(NFC) transceiver, and the first wireless communication protocol is aNFC protocol, wherein attaching the at least one electronic tag includesattaching a first NFC tag to the medical device and attaching a secondNFC tag to the sterile packaging, and wherein enclosing the medicaldevice in the sterile packaging includes enclosing the medical deviceand the first NFC tag inside the sterile packaging.
 18. The methodaccording to claim 17, wherein the processor controls the NFCtransceiver to write the pairing information into both the first NFC tagand the second NFC tag using the NFC protocol, while the medical deviceand the second NFC tag are contained inside the sterile packaging, andwherein the pairing information includes one or more of a wirelessidentifier, an encryption key, and a password which serves to associatethe medical device with the host device for secure communication witheach other.
 19. The method according to claim 18, further comprising:the medical device reading the pairing information from the first NFCtag integrated into the medical device, and transmitting a pairingrequest signal to the host device using the second wireless protocol,and wherein, in response to receiving the pairing request signal, theprocessor controls the host device to establish the wireless connectionwith the medical device using the pairing information read from thefirst NFC tag.
 20. The method according to claim 18, further comprising:the medical device reading the pairing information from the first NFCtag integrated into the medical device, and transmitting a pairingrequest signal to the host device using the second wireless protocol,wherein, in a case of not receiving the pairing request signal, theprocessor controls the host device to prompt a user to place the secondNFC tag integrated into the sterile packaging in close proximity to theNFC transceiver, wherein the processor controls the NFC transceiver toread the pairing information from the second NFC tag using the NFCprotocol, and wherein the processor controls the host device toestablish a secure wireless connection with the medical device using thepairing information read from the second NFC tag.